NL-OMON55824已完成4 期
MAASFLEX: A Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study to Evaluate the Effects of 2 Weeks Dapagliflozin Treatment on Nocturnal Substrate Oxidation, Glucose Metabolism and Muscle Mitochondrial Function in Individuals with Impaired Glucose Homeostasis - MAASFLEX
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of signed and dated informed consent prior to any study specific
- •procedures.
- •2. Males aged * 40 and * 75 years and post-menopausal women (defined as at
- •least 1 year post cessation of menses) aged * 50 and * 75 years
- •3. Body mass index (BMI) * 27 and * 38 kg/m2.
- •4. Sedentary lifestyle (not more than 2 hours of vigorous exercise per week).
- •5. Stable dietary habits.
- •6. Disrupted glucose homeostasis based on one or a combination of the following
- •- Impaired Glucose Tolerance (IGT): plasma glucose values * 7.8 mmol/l and *
- •11.1 mmol/l 120 minutes after consumption of the glucose drink during the 2h,
- •3-point OGTT.
- •- Impaired Fasting Glucose (IFG): fasting plasma glucose * 6.1 mmol/l and * 6.9
- •- Insulin Resistance: glucose clearance rate * 360 ml/kg/min, as calculated by
- •Oral Glucose Insulin Sensitivity 120 (OGIS120) model based on the 2h, 3-point
- •- HbA1c * 5.7% and * 6.4%.
排除标准
- •1. Clinical diagnosis of Type 1 or 2 Diabetes Mellitus.
- •2. Active cardiovascular disease
- •3. Weight gain or loss > 5 kg in the last 3 months, ongoing weight-loss diet
- •(hypocaloric diet) or use of weight loss agents.
- •4. Regular smoking and other regular nicotine use.
- •5. Anaemia.
- •6. Uncontrolled hypertension.
- •7. Clinically significant abnormalities in clinical chemistry or hematology
- •8. Unstable or rapidly progressing renal disease or estimated Glomeral
- •Filtration Rate (eGFR) <60 mL/min (Cockcroft-Gault formula).
- •9. Use of anti-coagulant treatment
- •10. Use of medication such as oral glucocorticoids, anti-estrogens or other
- •medications that are known to markedly influence insulin sensitivity.
- •11. Use of loop diuretics.
- •12. Intake of dietary supplements except multi-vitamins and minerals.
- •13. Alcohol consumption of > 14 drinks per week for women and > 21 drinks per
- •week for men.
- •14. Known hypersensitivity to dapagliflozin or any of the excipients of the
- •15. For women only - currently pregnant (confirmed with positive pregnancy
- •test) or breast-feeding.
- •16. Any contraindication for MRI scanning.
研究者
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